Dry eye is an ocular disease that results in symptoms of discomfort and visual disturbance as a result of decreased tear production, and is characterized by a dysfunction of one or more components of the tear film, the latter being stable in the absence of this disease. Tear deficiency may be caused by poor production of tears as a result of age, hormonal changes, various autoimmune diseases and other factors, and may be also a side effect of certain medications, such as beta-blockers, antidepressants, antihistamines etc. However, normal stable condition of the tear film resulting in normal tear secretion is important for the lubrication and maintenance of the refractive surface of the eye.
Dry eye may afflict an individual with varying degrees of severity, ranging from burning sensation, a feeling of dryness and persistent irritation up to substantial impairment of vision in more severe cases, vision may be substantially impaired. Therefore, a variety of approaches have been developed for treatment and therapy. Typically the majority of patients with dry eye syndrome are prescribed or recommended artificial tears. Other methods and devices that are also often recommended include scrubs, drops, inserts, plugs or lid compresses. These products typically comprise immunologic agents, autologous compounded serum, mucin producing agents or lubricants. While some such remedies do exist and may provide some relief in some cases, in many other instances they are insufficient or too expensive. Accordingly, it is desirable to have better alternative compositions.
This patent specification discloses such pharmaceutical compositions suitable for treatment and alleviation of dry eye disease that can achieve positive patient outcomes while free of drawbacks and deficiencies of existing formulations, and methods of fabricating and administering the same.